Clinical Trial Details

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A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer

Official Title

Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Hormone Receptor Positive Metastatic Breast Cancer Previously Exposed to Inhibitors of the PI3K Pathway: A Phase II Study With Pharmacodynamics Markers

Principal Investigator

Nanda, Rita

Brief Summary

Approximately 70 patients with HR+ advanced breast cancer will be enrolled. All patients
will receive either fulvestrant (500 mg IM every 2 weeks x 3 then every four weeks) or
tamoxifen (20 mg PO daily by physician choice). Pre-menopausal women must be in chemical
menopause.
Arm 1 will receive palbociclib 100 mg qd, days 1-21 every 28 days. Arm 2 will receive
palbociclib 125 mg qd, days 1-21 every 28 days. Restaging will be performed every 8 weeks.
Therapy will be continued until PD or unacceptable toxicity.
Patients will be randomly allocated in a 1:1 ratio to take either 100 mg or 125 mg of
palbociclib. Randomized treatment assignments will be made by permuted blocks, generated by
our collaborating statistician at Dana-Farber Cancer Institute.